C. von Holst, S. Bellorini, M. De Smet,

R. Fernandez-Orozco, M. J. Gonzalez de la

Huebra, J. Keltti, E. Kovacs, P. Robouch and Z. Ezerskis (Editor)

European Union Reference

Laboratory for Feed

Additives (EURL-FA) Authorisation

<Main subtitle, Verdana 16,Italic, line spacing 20pt>

Activity Report 2015

2016

JRC102843

This publication is a Technical report by the Joint Research C entre, the European C ommission’s in-house science

service. I t aims to provide evidence-based scientific support to the European policy-making process. The scientific

output expressed does not imply a policy posit ion of the European C ommission. Neither the European

C ommission nor any person ac ting on behalf of the C ommission is responsible for the use which might be made

of this publication.

JRC Science Hub

https://ec .europa.eu/jrc

JRC 102843

© European Union, 2016

Reproduc tion is authorised provided the source is acknowledged.

A ll images © European Union 2016

Activity Report 2015

of the

European Union Reference Laboratory

for Feed Additives Authorisation

<Main subtitle, Verdana 16,Italic, line spacing 20pt>

Table of contents

Executive summary ........................................................................................... 2

Declaration forms and sample management........................................................... 3

Evaluation of Dossiers........................................................................................ 3

Executive summary of the Workshop 2015 of the EURL-FA Authorisation .................... 8

Update of the administrative documents: EURL-FA Guidance for Applicants and Declaration Form ........................................... 9

EURL support to the Commission ........................................................................ 10

The Diclazuril Collaborative Trial ......................................................................... 10

The Optiphos conversion factor........................................................................... 11

The EURL a peer reviewed publication on its activity............................................... 12

Acknowledgements........................................................................................... 12

Annex I: List of the NRLs of the EURL-FA network............................................. 13

Annex II: List of EURL FAD reports issued in 2015 ............................................. 15

2

Executive summary

This report presents the main achievements of the European Union Reference Laboratory

for feed additives authorisation (later referred as EURL) in 2015. The tasks of the EURL

regarding the authorisation of feed additives are specified in Regulation (EC)

No 378/2005, last amended by Commission Implementing Regulation (EU) 2015/1761.

The main achievements of the EURL are:

- The sample registration and maintenance of the sample bank of reference feed

additives;

- The scientific evaluation of analytical methods submitted by the applicants; and

- The organisation of 15th annual EURL workshop with National Reference

Laboratories (NRLs), to discuss topics related to the authorisation of feed

additives.

In addition, the EURL:

- Updated two administrative documents: the Declaration Form and the Guidance

for Applicants;

- Contributed to the amendment of Commission Regulation (EC) No 378/2005 by

Commission Implementing Regulation (EU) 2015/1761;

- Contributed to the organisation of a collaborative trial to improve the Community

method for determination of Diclazuril.

3

Declaration forms and sample management

When applying for the authorisation of a feed additive, Applicants send a Declaration

Form (DF) to the EURL. The details included allow the establishment of the fee to be

paid. In 2015, a total of 42 DF were processed. As for reference samples a total of 317

samples were processed by EURL, to include 40 new samples, 132 replacement samples

and 145 shelf-life extensions.

Evaluation of Dossiers

In 2015 the EURL evaluated 50 applications and issued a total of 47 reports (including

the amendment of a 2011 report) with the support of the National Reference

Laboratories (NRLs). Table 1 presents the number of applications submitted by the

Applicants and the number of reports evaluated by the EURL since 2009. Since 2013 the

number of the applications and reports is similar, indicating the end of the "grouping" of

applications. Twelve (out of 47) reports - mainly related to micro-organisms - were

evaluated and drafted by the following four NRLs: CRA-W,BE (6), CReAA,IT (2),

AGES,AT and PIWET,PL. The evaluation process was co-ordinated by the EURL.

Table 1 also includes the number of corresponding EFSA opinions and Commission

Implementing Regulations, CIR (Table 1) published in 2009 to 2015 based on the EURL

recommendations. The list of all the EURL report issued in 2015 is provided in Annex II

and the reports are available from the EURL webpage:

https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.

Tables 2 and 3 list the EFSA opinions and the CIR published in 2015 based on or

including the EURL recommendations.

Table 1. Number of applications evaluated, evaluation reports, EFSA opinions and CIR

issued since 2009

2009 2010 2011 2012 2013 2014 2015

Applications 24 70 124 92 36 51 50

EURL Reports 24 68 87 59 32 44 47

EFSA opinions 24 22 54 74 50 34 35

CIR 18 20 46 36 39 26 38

4

Table 2. EURL executive summaries included in EFSA opinions published in 2015

EFSA Journal

reference Feed additives/Active substances

Dossier

number

1 2015;13(12):4198 Lactic acid and calcium lactate 2010-0133

2 2015;13(11):4272 Ethoxyquin (6-ethoxy-1,2-dihydro-2,2,4-trimethylquinoline) 2010-0141

3 2015;13(11):4275 Axtra® PHY 15 000 L (6-phytase) 2013-0049

4 2015;13(11):4274 Calsporin® (Bacillus subtilis DSM 15544) 2009-0013

5 2015;13(11):4273 Liderfeed® (eugenol) 2010-0396

6 2015;13(11):4267 Zinc chelate of L-lysinate-HCl 2014-0021

7 2015;13(11):4271 Sodium selenite (coated granulated preparation) 2010-0369

8 2015;13(11):4268 Saturated and unsaturated aliphatic secondary alcohols, ketones and esters with esters containing secondary

alcohols belonging to chemical group 5 2010-0074

9 2015;13(9):4238 L-tryptophan, technically pure, produced by Escherichia coli strains DSM 25084, KCCM 11132P or

SARI12091203 2010-0056

10 2015;13(9):4236 L-threonine produced by Escherichia coli strains NRRL B-30843, DSM 26131, KCCM11133P or DSM 25085 2010-0058

11 2015;13(9):4239 Sorbic acid and potassium sorbate 2010-0145

2010-0193

12 2015;13(9):4230 Bacillus subtilis KCCM 10673P and Aspergillus oryzae KCTC 10258BP 2009-0007

13 2015;13(7):4155 L-lysine sulphate produced by fermentation with Escherichia coli CGMCC 3705 2013-0045

14 2015;13(7):4160 Lignosulphonate 2010-0209

15 2015;13(7):4159 ENZY PHOSTAR® (6-phytase) 2012-0044

16 2015;13(7):4158 Cylactin® (Enterococcus faecium NCIMB 10415) 2010-0269

17 2015;13(5):4113 Formic acid, ammonium formate and sodium formate

2009-0027

2010-0188

2010-0303 2010-0312

18 2015;13(5):4110 L-valine (L-valine, feed grade) produced by Escherichia coli NITE BP-01755 2014-0015

19 2015;13(5):4109 Ferrous carbonate 2010-0380

20 2015;13(5):4114 Complexation products of sodium tartrates with iron(III) chloride 2012-0035

21 2015;13(5):4108 Indigo carmine (E 132) 2010-0346

22 2015;13(5):4056 Ammonium formate, calcium formate and sodium formate 2010-0312

23 2015;13(5):3794 AviMatrix® (benzoic acid, calcium formate and fumaric acid) 2012-0037

24 2015;13(4):4057 Cupric acetate, monohydrate; basic cupric carbonate, monohydrate; cupric chloride, dihydrate; cupric oxide;

cupric sulphate, pentahydrate; cupric chelate of amino acids, hydrate; cupric chelate of glycine, hydrate 2010-0031

25 2015;13(3):4055 Cibenza® EP150 (a preparation of Bacillus licheniformis (ATCC 53757) 2013-0017

26 2015;13(3):4053 Aliphatic and aromatic hydrocarbons (chemical group 31) 2010-0022

27 2015;13(2):4014 Hexamethylene tetramine 2010-0377

28 2015;13(2):4011 XTRACT® Evolution-B, Code X60-6930 (carvacrol, cinnamaldehyde and capsicum oleoresin) 2013-0010

29 2015;13(2):4012 L-methionyl-DL-methionine 2012-0034

30 2015;13(2):4009 Citric acid 2010-0357

31 2015;13(2):4010 Citric acid

2010-0154

2010-0187

2010-0357

32 2015;13(1):3968 Coxiril® (diclazuril) 2013-0042

33 2015;13(1):3971 Glycyrrhizic acid ammoniated (chemical group 30, miscellaneous substances) 2010-0115

34 2015;13(1):3903 Suilectin (Phaseolus vulgaris lectins) 2010-0079

35 2015;13(1):3965 L-valine produced by Escherichia coli NITE SD 00066 2012-0023

EFSA opinions on: http://www.efsa.europa.eu/en/publications/efsajournal.htm;

EURL reports on: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

5

Table 3. Commission Implementing Regulations published in 2015 and supported by

the EURL recommendations

Commission Implementing

Regulation (EU) No Feed additives/active substance

Dossier

number

1 2015/38 of 13 January 2015 Lactobacillus acidophilus CECT 4529 2010-0394

2 2015/46 of 14 January 2015 Diclazuril 2012-0017

2013-0014

3 2015/47 of 14 January 2015 Alpha-amylase produced by Bacillus licheniformis (DSM 21564) 2010-0009

4 2015/244 of 16 February 2015 Quinoline Yellow 2010-0345

5 2015/264 of 18 February 2015 Neohesperidine dihydrochalcone 2010-0158

6 2015/489 of 23 March 2015 Selenomethionine produced by Saccharomyces cerevisiae NCYC R645 2009-0010

7 2015/502 of 24 March 2015 Saccharomyces cerevisiae NCYC R404 2012-0038

8 2015/518 of 26 March 2015 Enterococcus faecium NCIMB 10415 2008-0021

9 2015/661 of 28 April 2015 Endo-1,4-beta-xylanase and endo-1,3(4)-beta- glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702

2013-0030

10 2015/662 of 28 April 2015 L-carnitine and L-carnitine L-tartrate 2010-0225

2010-0144

11 2015/722 of 5 May 2015 Taurine 2010-0215

12 2015/723 of 5 May 2015 Biotin 2010-0100

13 2015/724 of 5 May 2015 Retinyl acetate, retinyl palmitate and retinyl propionate 2010-0200

14 2015/861 of 3 June 2015 Potassium iodide, calcium iodate anhydrous and coated granulated calcium iodate anhydrous

2010-0148

2010-0223 2010-0231

2010-0370

15 2015/897 of 11 June 2015 Thiamine hydrochloride and thiamine mononitrate

2010-0040

2010-0052

2010-0140

16 2015/1020 of 29 June 2015 Bacillus subtilis (ATCC PTA-6737) 2008-0039

17 2015/1043 of 30 June 2015 Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) 2010-0001

18 2015/1053 of 1 July 2015 Enterococcus faecium DSM 10663/NCIMB 10415 2012-0001

2010-0150

19 2015/1060 of 2 July 2015 Betaine anhydrous and betaine hydrochloride

2010-0174

2010-0216 2010-0253

20 2015/1061 of 2 July 2015 Ascorbic acid, sodium ascorbyl phosphate, sodium calcium ascorbyl phosphate, sodium

ascorbate, calcium ascorbate and ascorbyl palmitate

2010-0214

2010-0185

21 2015/1103 of 8 July 2015 Beta-carotene 2009-0046

22 2015/1104 of 8 July 2015 Alpha- galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and

endo-1,4-beta- glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) 2009-0014

23 2015/1105 of 8 July 2015 Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM

16351 and Enterococcus faecium DSM 21913 2014-0011

24 2015/1114 of 9 July 2015 L-valine produced by Escherichia coli 2012-0023 2014-0015

25 2015/1152 of 14 July 2015 Tocopherol extracts from vegetable oils, tocopherol-rich extracts from vegetable oils (delta

rich) and alpha-tocopherol

2010-0105

2010-0271

26 2015/1408 of 19 August 2015 DL-methionyl-DL-methionine 2012-0034

27 2015/1415 of 20 August 2015 Astaxanthin 2009-0054

28 2015/1416 of 20 August 2015 Sodium bisulphate 2009-0049

29 2015/1417 of 20 August 2015 Diclazuril 2013-0042

30 2015/1426 of 25 August 2015 Benzoic acid, thymol, eugenol and piperine 2013-0052

31 2015/1486 of 2 September 2015 Canthaxanthin 2008-0048

32 2015/1489 of 3 September 2015 Lactobacillus plantarum NCIMB 30238 and Pediococcus pentosaceus NCIMB 30237 2010-0048

2010-0127

33 2015/1490 of 3 September 2015 Carvacrol, cinnamaldehyde and capsicum oleoresin 2013-0010

34 2015/2304 of 10 December 2015 Endo-1,4-beta-xylanase and endo-1,3(4)-beta- glucanase produced by Talaromyces versatilis

sp. nov. IMI CC 378536 and Talaromyces versatilis sp. nov DSM 26702 2013-0030

35 2015/2305 of 10 December 2015 Endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM

SD142) 2010-0062

36 2015/2306 of 10 December 2015 L-cysteine hydrochloride monohydrate 2010-0152

37 2015/2307 of 10 December 2015 Menadione sodium bisulphite and menadione nicotinamide bisulphite 2010-0099

38 2015/2382 of 17 December 2015 Alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604)

2009-0014

Commission Implementing Regulations on: http://ec.europa.eu/food/safety/docs/animal-feed-eu-reg-comm_register_feed_additives_1831-03.pdf

EURL reports on: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

6

Table 4. Categories / functional groups of feed additives evaluated in 2015

Category Functional Group 2015

1 technological a preservatives

b antioxidants 1

c emulsifiers 2

d stabilisers 1

e thickeners 1

f gelling agents 1

g binders 2

h substances for control of radionuclide contamination

i anticaking agents 8

j acidity regulators 2

k silage additives 3

l denaturants

m mycotoxin binders 1

2 sensory a colourants 1

b flavouring compounds 2

3 nutritional a vitamins, pro-vitamins 5

b compounds of trace elements 5

c amino acids

d urea and its derivatives

4 zootechnical a digestability enhancers 7

b gut flora stabilisers: micro-organisms 7

c substances which favourably affect the environment 1

d other zootechnical additives 1

5 coccidiostats & histomonostats

3

Total 54

Table 4 presents a detailed overview of the "categories" / "functional groups" evaluated

by the EURL in 2015, resulting in 22 technological, 16 zootechnical, 10 nutritional,

3 sensory and 3 coccidiostats & histomonostats dossiers.

As foreseen by Commission Regulation (EC) No 378/2005, every draft "initial" report was

reviewed by experts of the various NRL. Their critical and constructive remarks

contributed to the quality reports sent by the EURL to the European Food Safety

Authority (EFSA) and Directorate General of the European Commission (DG SANTE).

These comments are highly appreciated by the EURL and the NRL contribut ions are

systematically acknowledged in the final reports. Figure 1 shows the review activity of

the NRLs in 2015, where four NRLs commented to 30 or more initial reports: CZ-UKZUZ,

PL-PIWET, IT-CReAA and FR-SCL.

7

Figure 1 Number of draft reports commented by NRLs during the 2015 review

process

CZ-UKZUZ – Ústřední kontrolní a zkušební ústav zemědělský (ÚKZÚZ), Praha (Czech Republic)

PL-PIWET – Państwowy Instytut Weterynaryjny, Pulawy (Poland)

IT-CReAA – Centro di referenza nazionale per la sorveglienza ed il controllo degli alimenti per gli animali

(CReAA), Torino (Italy)

FR-SCL – Laboratoire de Rennes (SCL L35), Service Commun des Laboratoires DGCCRF et DGDDI, Rennes

(France)

DE-TLL – Thüringer Landesanstalt für Landwirtschaft (TLL). Abteilung Untersuchungswesen. Jena

(Germany)

AT-AGES – Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES), Wien (Austria)

DK-PD – Fødevarestyrelsens Laboratorie Aarhus (kemisk) (Denmark)

DE-SMUL – Staatliche Betriebsgesellschaft für Umwelt und Landwirtschaft. Geschäftsbereich 6 — Labore

Landwirtschaft, Nossen (Germany)

SI-VFUNIV – Univerza v Ljubljani. Veterinarska fakulteta. Nacionalni veterinarski inštitut. Enota za

patologijo prehrane in higieno okolja, Ljubljana (Slovenia)

NL-RIKILT – RIKILT Wageningen UR, Wageningen (The Netherlands)

ES-MAGRAMA – Laboratorio Arbitral Agroalimentario. Ministerio de Agricultura, Alimentación y Medio

Ambiente, Madrid (Spain)

DE-LGL – Sachgebiet Futtermittel des Bayrischen Landesamtes für Gesundheit und Lebensmittelsicherheit

(LGL), Oberschleißheim (Germany)

PL-IZOO – Instytut Zootechniki — Państwowy Instytut Badawczy, Krajowe Laboratorium Pasz, Lublin

(Poland)

BE-CRAW - Centre wallon de Recherches agronomiques (CRA-W), Gembloux (Belgium)

SE-SVA Avdelningen för kemi, miljö och fodersäkerhet, Statens Veterinärmedicinska Anstalt (SVA),

Uppsala (Sweden)

ES-GENCAT – Laboratori Agroalimentari, Departament d'Agricultura, Ramaderia, PESCA, Alimentació i

Medi Natural. Generalitat de Catalunya, Cabrils (Spain)

Fi-EVIRA – Elintarviketurvallisuusvirasto/Livsmedelssäkerhetsverket (Evira), Helsinki/Helsingfors (Finland)

IT-ISS – Istituto Superiore di Sanità. Dipartimento di Sanità Pubblica Veterinaria e Sicurezza Alimentare,

Roma (Italy)

BE-FAVV – Federaal Laboratorium voor de Voedselveiligheid Tervuren (FLVVT –FAVV); (Belgium)

LV-VVMDC – Pārtikas drošības, dzīvnieku veselības un vides zinātniskais institūts BIOR, Rīga (Latvia)

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8

Executive summary of the Workshop 2015 of the EURL-FA Authorisation

The 15th workshop (WS) of the EURL Feed Additives (EURL-FA) Authorisation was

organised and held at IRMM on November 16 - 17, 2015. A total of fourty participants

representing 19 National Reference Laboratories (NRLs), DG SANTE, EFSA and EURL-FA.

In addition the EU Association of Specialty Feed Ingredients and their Mixtures (FEFANA)

attended the public part of the event.

C. von Holst (operating manager of EURL-FA) welcomed the participants and presented

the programme of the workshop. The workshop started with presentation on EURL-FA

Authorisation activities of 2015, deliverables and work programme of 2016 given by the

EURL colleagues. Beside evaluation of the dossiers from Applicants, the additional

activities of the EURL included the work on: i) Diclazuril and Optiphos projects; ii) text of

Commission implementing Regulation (EU) 2015/1761 amending the current legislation

(EC) 378/2005; and iii) compilation of the recommended methods for their further

containment in EURL-FA web site.

C. von Holst continued with the presentation on the role of the EURL in the case of the

applications related to new use of feed additives (art. 4 (1)) and for the applications

where the terms of authorisation for existing feed additives were changed (art. 13(3)),

focusing on more detailed explanation on the role of the EURL for the future applications

related to renewal of authorisations according article 14.

A. Rodriguez (DG SANTE) gave detailed overview on the re-evaluation status of

chemically and botanically defined flavourings. In addition, new functional groups such

as hygiene condition enhancers, identifiers and other technological feed additives were

presented.

FEFANA continued with the analytical aspects related to the analysis of flavouring

compounds, pointing out that the methods for determination of individual substances in

the flavouring formulations are feasible, while the determination of individual

components in feed is challenging due too low maximum legal limits established.

Then, the EURL colleagues presented the pitfalls related to application of Community

method (EC 152/2009) for determination of Diclazuril in feed and the results of

collaborative trial using the corrected Community method. Based on the results of the

exercise it was concluded by the EURL&NRLs authorisation and control networks that the

corrected method will replace the current Community method in the revised Commission

Regulation.

The other presentations involved the following topics: i) uncertainty from sample

preparation in the case of feed additives (W. Korol, Polish NRL); ii) analysis of TiO2 for

the presence of nanoparticles (J. Omar, EURL); iii) EFSA status report on 2015 - update

on the re-evaluation process (M. Innocenti, EFSA); iv) update on Optiphos project

aiming at determination of conversion factor that would enable the labelling control of

Optiphos feed products when applying the ISO 30024 (M. J. Gonzalez de la Huebra).N

9

Three NRLs: AGES (AT), EVIRA (FI) and PIWET (PL) presented the posters on the

structure of their organisations and work activities. In addition, the Polish NRL (IZOO)

presented the posters on the organisation of PTs and HPLC method for determination of

Vitamin C in feeds, and Spanish NRL (GENCAT) presented the paper copy of desorption

electrospray ionization-high resolution mass spectrometry for the screening of veterinary

drugs in cross-contaminated feedstuffs. The overall feedback from participants was very

positive, the balance between formal presentations and discussions was well perceived.

Update of the administrative documents: EURL-FA Guidance for

Applicants and Declaration Form

In 2015, the EURL updated the "Guidance for Applicants of feed additives authorisation",

related to the EURL core activities. The current document (ver 3.01) introduces new

approaches concerning the management of reference samples and dossier evaluation.

https://ec.europa.eu/jrc/sites/default/files/EURL-FA_Guidance_for_Applicants-ver3.01.pdf

At present, reference samples are not required when an application is submitted

according to:

1. Article 4(1) of Regulation (EC) No 1831/2003 for a new use of an already

authorised feed additive; or

2. Article 13 (3) for changing the terms of an existing authorisation; or

3. Article 14 for renewal of an existing authorisation.

These provisions apply only if the proposed modification of the terms of the

authorisation does not alter the composition and the characteristics of the product.

During the authorisation process, the Applicant must provide replacement samples to

replace the expired samples. As soon as the feed additive is authorised, no replacement

samples are required during the entire authorisation period.

Replacement samples are to be provided for applications submitted according to Article 4

(1) of Regulation (EC) No 1831/2003 (new use of a feed additive) if the original

reference samples are expired.

Note: The EURL is entitled to request the Applicant to provide additional reference

samples, whenever deemed necessary. In addition,

As for the evaluation of dossiers, the EURL report is not required when the application

is submitted according to: Article 4 (1); or Article 13 (3); or Article 14 of Regulation (EC)

No 1831/2003.

These provisions apply only when:

- the methods of analysis for the determination of the concerned feed additive

submitted according to Regulation (EC) No 429/2008 (including the relevant

validation and verification studies) were already evaluated by the EURL; or

- The proposed conditions for the new use or the proposed modification of the

conditions fall within the scope of the methods already evaluated by the EURL.

The Declaration Form (ver. 2) was updated accordingly to reflect these new changes.

https://ec.europa.eu/jrc/sites/default/files/new_2015-declaration-form_v2.doc

10

EURL support to the Commission

In 2015, the EURL contributed to Commission Implementing Regulation (EU) 2015/1761

of 1 October 2015 amending Commission Regulation (EC) No 378/2005 as regards the

Community Reference Laboratory reports, fees and the laboratories listed in Annex II

thereto.

This document specifies new rules related to the EURL evaluation and the fees for

applications for renewal of feed additives authorisation according Article 14. In such

cases, no EURL evaluation/report is required when properly validated and verified

methods were submitted and already evaluated by the EURL. Furthermore, no reference

samples are to be delivered by the Applicant to the EURL. Consequently, no payment will

be invoiced by the EURL to the Applicant.

This document also provides an exhaustive up-to-date list of the National Reference

Laboratories, including correct institute names and addresses. This resulted in the

addition of one NRL from Greece.

The Diclazuril Collaborative Trial

In 2013, several NRLs acknowledged the fact that the standard operating procedure

described in Commission Regulation (EC) No 152/2009 for the determination of a Diclazuril

in feed was not fit-for-purpose if applied as such. The EURL identified several experimental

conditions that need to be modified or improved. The modified/improved method was then

single-laboratory validated by the EURL and satisfactory results for the method

performance characteristics were obtained.

Based on these results, the EURL decided together with the network of NRLs to organise

in 2015 a collaborative trial to assess the method performance characteristics of this

modified method based on high performance liquid chromatography coupled to

spectrophotometric detection (LC-UV or LC-DAD) for the determination of Diclazuril in

feed. This project was than conducted by the EURL-FA control, which operates under

Regulation (EC) No 882/2004. A total of 5 samples (4 blind duplicates + 1 blank feed)

were analysed by 14 laboratories. The following performance characteristics were

derived from the reported results: - a relative standard deviation for repeatability (RSDr)

ranging from 4.5 % to 11 %; and - a relative standard deviation for reproducibility

(RSDR) ranging from 14 % to 18 %, thus resulting to satisfactory Horrat ratios below

1.5. Based on these satisfactory results, the NRLs agreed that the EURL should

recommend DG SANTE to revise the current Community method. The draft of the text

describing the "improved" experimental protocol to be included in the revised Regulation

replacing (EC) No 152/2009 was drafted by the EURL and reviewed by the concerned

NRLs.

11

The Optiphos conversion factor

The EURL started in 2015 the preparation for an inter-laboratory comparison aiming at

the establishment of the conversion factor (f) enabling the labelling control of Optiphos

feed products when applying the ISO 30024 analytical method.

Several challenges were already identified in 2014: - the lack of a suitable phytate

substrate; and - the lack of a clear standard operational procedure for quantif ication of

6-Phytase in the feed additives.

Nevertheless, some progress was made in the 2015:

the feasibility study for testing equivalence of commercially available phytate

substrates was performed by two NRLs (France and Denmark);

a preliminary ring trial was organised by the VDLUFA Enzyme group to extend the

scope of the ISO method to feed additives. An Optiphos formulation (feed

additive) was included and satisfactory results were obtained;

consequently, a ring trial was organised by VDLUFA to extend the scope of the

ISO 30024 standard method to the determination of 6-phytase in feed additives.

Satisfactory results were reported. The extended method thus became an official

VDLUFA method for the determination of phytase activity in feed additives;

A dedicated meeting was organised by the EURL with the Chair of the VDLUFA

Enzyme Group (AGES) to fine-tune practical details regarding the Optiphos assay

(e.g. samples to be analysed and time planning).

12

The EURL a peer reviewed publication on its activity

Food Additives & Contaminants: Part A

Volume 33, Issue 1, 2016, pages 66-77

Review Article

The work of the European Union Reference Laboratory for Feed Additives (EURL) and its support for the authorisation process of feed additives in the European Union: a review

DOI: 10.1080/19440049.2015.1116127

Christoph von Holst, Piotr Robouch,

Stefano Bellorini, María José González de la Huebra & Zigmas Ezerskis

Received: 18 Sep 2015

Accepted: 1 Nov 2015 Published online: 03 Dec 2015

© 2015 European Union.

Published by Taylor & Francis.

ABSTRACT

This paper describes the operation of the European Union Reference Laboratory for Feed Additives (EURL) and its role in the authorisation procedure of feed additives in the European Union. Feed additives are authorised according to Regulation (EC) No. 1831/2003, which introduced a completely revised authorisation procedure and also established the EURL. The regulations authorising feed additives contain conditions of use such as legal limits of the feed additives, which require the availability of a suitable method of analysis for official control purposes under real world conditions. It is the task of the EURL to evaluate the suitability of analytical methods as proposed by the industry for this purpose. Moreover, the paper shows that one of the major challenges is the huge variety of the methodology applied in feed additive analysis, thus requiring expertise in quite different analytical areas. In order to cope with this challenge, the EURL is supported by a network of national reference laboratories (NRLs) and only the merged knowledge of all NRLs allows for a scientifically sound assessment of the analytical methods.

Acknowledgements

The EURL would like to thank our colleagues within DG JRC IRMM for their strong

support and interest in EURL-FA activities, related to secretarial support, review of

reports and development of tailor-made informatics systems. The efforts and

excellent collaboration with the Mail services and the Resources Management Geel

are also acknowledged.

We are grateful to all the NRL experts for their valuable contribution in the

evaluation of the dossiers and the constructive discussions during the workshop. All

this allowed successful evaluations and guaranteed proper dissemination of

knowledge and good practices. The list of NRLs is provided in Annex I.

Finally we would like to wish all the best to our colleagues who left the EURL team:

Johanna Keltti, Edit Kovacs and Rebeca Fernandez-Orozco. Their contribution was

essential to the successful activity of the EURL.

13

Annex I: List of the NRLs of the EURL-FA network

(updated on 15/03/2016)

Country National Reference Laboratory

- Federaal Laboratorium voor de Voedselveiligheid Tervuren (FLVVT –FAVV). BE - Vlaamse Instelling voor Technologisch Onderzoek (VITO), Mol. BE

- Centre wallon de Recherches agronomiques (CRA-W), Gembloux. BE

- Ústřední kontrolní a zkušební ústav zemědělský (ÚKZÚZ), Praha. CZ

- Fødevarestyrelsens Laboratorie Aarhus (kemisk). DK

- Fødevarestyrelsens Laboratorie Ringsted (kemisk og mikrobiologisk). DK

- Sachgebiet Futtermittel des Bayrischen Landesamtes für Gesundheit und

Lebensmittelsicherheit (LGL), Oberschleißheim. DE

- Landwirtschaftliche Untersuchungs- und Forschungsanstalt (LUFA), Speyer. DE

- Staatliche Betriebsgesellschaft für Umwelt und Landwirtschaft. Geschäftsbereich 6 -

Labore Landwirtschaft, Nossen. DE

- Thüringer Landesanstalt für Landwirtschaft (TLL). Abteilung Untersuchungswesen.

Jena. DE

- Põllumajandusuuringute Keskus (PMK). Jääkide ja saasteainete labor, Saku,

Harjumaa. EE

- Põllumajandusuuringute Keskus (PMK), Taimse materjali labor, Saku, Harjumaa. EE

- Laboratorio Arbitral Agroalimentario. Ministerio de Agricultura, Alimentación y

Medio Ambiente, Madrid. ES

- Laboratori Agroalimentari, Departament d'Agricultura, Ramaderia, PESCA,

Alimentació i Medi Natural. Generalitat de Catalunya, Cabrils. ES

- Laboratoire de Rennes (SCL L35), Service Commun des Laboratoires DGCCRF et

DGDDI, Rennes. FR

- The State Laboratory, Kildare. IE

- Εργαστήριο Ελέγχου Κυκλοφορίας Ζωοτροφών Θεσσαλονίκης. GR

- Istituto Superiore di Sanità. Dipartimento di Sanità Pubblica Veterinaria e Sicurezza

Alimentare, Roma. IT

- Centro di referenza nazionale per la sorveglienza ed il controllo degli alimenti per gli

animali (CReAA), Torino. IT

- Feedingstuffs Analytical Laboratory, Department of Agriculture, Nicosia. CY

- Pārtikas drošības, dzīvnieku veselības un vides zinātniskais institūts BIOR, Rīga. LV

14

Country National Reference Laboratory

- Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas, Vilnius. LT

- Laboratoire de Contrôle et d'essais — ASTA, Ettelbruck. LU

- Nemzeti Élelmiszerlánc-biztonsági Hivatal, Élelmiszer- és Takarmánybiztonsági

Igazgatóság, Takarmányvizsgáló Nemzeti Referencia Laboratórium, Budapest. HU

- RIKILT Wageningen UR, Wageningen. NL

- The National Institute of Nutrition and Seafood Research (NIFES), Bergen. NO

- Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES), Wien. AT

- Instytut Zootechniki — Państwowy Instytut Badawczy, Krajowe Laboratorium Pasz,

Lublin. PL

- Państwowy Instytut Weterynaryjny, Pulawy. PL

- Instituto Nacional de Investigação Agrária e Veterinária, I.P. (INIAV,IP), Lisboa. PT

- Univerza v Ljubljani. Veterinarska fakulteta. Nacionalni veterinarski inštitut. Enota

za patologijo prehrane in higieno okolja, Ljubljana. SI

- Kmetijski inštitut Slovenije, Ljubljana. SI

- Skúšobné laboratórium analýzy krmív, Ústredný kontrolný a skúšobný ústav

poľnohospodársky, Bratislava. SK

- Elintarviketurvallisuusvirasto/Livsmedelssäkerhetsverket (Evira),

Helsinki/Helsingfors. FI

- Avdelningen för kemi, miljö och fodersäkerhet, Statens Veterinärmedicinska Anstalt

(SVA), Uppsala. SE

- LGC Ltd, Teddington. UK

- European Commission, Joint Research Centre, Institute for Reference Materials and

Measurements (IRMM). EU

15

Annex II: List of EURL FAD reports issued in 2015 (listed in anti-chronological order)

FAD No Product Name Active Substance(s) Published on NRL

2010-0213 Feedlyve® AXC Endo 1,4-β-xylanase 11/12/2015

2010-0367 Enzymes as silage additives

Alpha-amylase EC 3.2.1.1 Endo-1,4-beta-glucanase EC 3.2.1.4 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Endo-1,4-beta-xylanase EC 3.2.1.8

08/12/2015 AT-AGES

2010-0309 Precipitated and dried silicic acid

27/11/2015

2013-0055 SmokeEz C-10 Primary Smoke Condensate – Smoke flavouring

23/11/2015

2014-0036 2014-0045

Maxiban®G160 Narasin; Nicarbazin 13/11/2015

2015-0014 Lactobacillus brevis TAK 124-1 NCIMB 42149

Lactobacillus brevis TAK 124-1 NCIMB 42149

30/10/2015 IT-CReAA

2015-0013 Lactobacillus plantarum TAK 59 NCIMB 42150

Lactobacillus plantarum TAK 59 NCIMB 42150

23/10/2015 BE-CRA-W

2015-0016 B-Act® Bacillus licheniformis BL 11 (DSM 28710)

23/10/2015 BE-CRA-W

2013-0020 Iron Dextran Iron 19/10/2015

2010-0341 Synthetic Calcium Silicate Calcium Silicate 30/09/2015

2014-0029 Bergazym P100 Endo 1,4-β-xylanase 24/09/2015

2015-0002 Zinc Chelate of Methionine Zinc Chelate of Methionine 15/09/2015

2010-0238 Natrolite-phonolite E566 Natrolite-phonolite 04/09/2015

2014-0037 Bacillus subtilis DSM 27273 Bacillus subtilis DSM 27273 25/08/2015 IT-CReAA

2014-0031 Betaine anhydrous Betaine 21/08/2015

2014-0047 Preparation of algae interspaced bentonite

18/08/2015

2010-0226 Precipitated and dried silicic acid Colloidal silica

18/08/2015

2011-0023 Ethyl Cellulose 12/08/2015

2014-0001 Hemicell® Endo-1,4-β-mannanase (E.C. 3.2.1.78) 12/08/2015 PL-IZOO

2015-0008 Enviva® PRO 202 GT Bacillus amyloliquefaciens BS 15A-P4, Bacillus amyloliquefaciens LSSAO1, Bacillus amyloliquefaciens BS 2084

07/08/2015 BE-CRA-W

2015-0006 Bacillus subtilis DSM 28343 Bacillus subtilis DSM 28343 30/07/2015 BE-CRA-W

2010-0293 Stenorol® Halofuginone hydrobromide 29/07/2015

2014-0006 Fecinor Enterococcus faecium CECT 4515 30/06/2015 IT-CReAA

2014-0016 Salinomax® 120G Salinomycin Sodium 12/06/2015

16

FAD No Product Name Active Substance(s) Published on NRL

2014-0044 Natuphos®E 6-phytase 10/06/2015

2012-0021 Tertiary-Butylhydroquinone (TBHQ)

Tertiary-Butylhydroquinone 08/06/2015

2013-0047 Ronozyme® WX Endo 1,4-β-xylanase 04/06/2015

2010-0096 Natural mixture of talc and chlorite

Natural mixture of talc and chlorite 29/05/2015

2010-0248 Omega-6-fatty acid as octadecadienoic acid

Conjugated linoleic acid-methylester (trans-10, cis-12-isomer)

29/05/2015

2011-0018c Vitamin K3 (Menadione) Menadione Dimethyl Pyrimidinol Bisulphite

26/05/2015

2010-0128 Vermiculite Vermiculite 26/05/2015

2010-0061 Natrolite-phonolite E566 Natrolite-phonolite 25/03/2015

2010-0100 Biotin D-(+)-Biotin 25/03/2015 addendum

2014-0034 Dicopper oxide Dicopper oxide 24/03/2015

2013-0048 Lavipan®

Lactococcus lactis IBB500; Carnobacterium divergens S1; Lactobacillus casei LOCK 0915; Lactobacillus plantarum LOCK 0862; Saccharomyces cerevisiae LOCK 0141;

11/03/2015 BE-CRA-W

2010-0398 Lipidol Lecithins E322 Lecithins 09/03/2015

2014-0022 Proccanius Lactobacillus fermentum NCIMB 41636; Lactobacillus plantarum NCIMB 41638; Lactobacillus rhamnosus NCIMB 41640

26/02/2015 BE-CRA-W

2013-0035 Alpha-lipoic acid Alpha-lipoic acid 24/02/2015

2010-0149 Sodium Selenate Sodium Selenate 24/02/2015

2010-0012 Perlite Sodium potassium aluminum silicate 24/02/2015

2013-0017 Cibenza® EP150 Protease EC 3.4.21.19; Bacillus licheniformis ATCC 53757

20/02/2015

2010-0104 2010-0362 2010-0369

Sodium selenite Sodium selenite 20/02/2015

2010-0364 Lecithins E322 Lecithins 11/02/2015

2010-0147 Benzoic acid E210 Benzoic acid 14/01/2015

2010-0306 Lutein Lutein 13/01/2015

2010-0120 Levucell SC Saccharomyces cerevisiae CNCM I-1077 09/01/2015 IT-CReAA

2010-0121 Levucell SB Saccharomyces cerevisiae CNCM I-1079 09/01/2015 PL-PIWET

Reports available from the EURL website: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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where you can place an order with the sales agent of your choice.

The Publications O ffice has a worldwide network of sales agents.

You can obtain their contact details by sending a fax to (352) 29 29-42758.

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